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  1. Center for Drug Evaluation and Research | CDER

Botanical Review Team (BRT)

What is a Botanical Drug?

Frequently Asked Questions on Botanical Drug Development

Related Botanical Links

About the Botanical Review Team

The CDER Botanical Review Team (BRT) resides in the Office of Pharmaceutical Quality (OPQ), and is a part of OPQ's Science Staff. The BRT has scientific expertise on a wide range of botanical issues, particularly the complexities associated with natural products and the inherent challenges associated with natural product drug development. The team also ensures consistent interpretation of the Botanical Drug Development Guidance for
Industry.

Please send all inquiries regarding botanicals to [email protected]

What We Do

  • The BRT participates in all phases of review, meetings and decision-making processes for all botanical pre-Investigational New Drug (PIND) applications, Investigational New Drug (IND) applications, Biological License Applications (BLA), Abbreviated New Drug Applications (ANDA), New Drug Applications (NDA), 505 B Compounding, and Homeopathic Products.
  • The BRT follows the review process for INDs and NDAs for botanical drug products described in MaPP 5210.9 Rev 1.
  • The BRT responds to external constituents who have general botanical drug development questions. 
  • The BRT responds to issues and meeting requests from FDA's Office of the Commissioner and works on common botanical issues with
  • The BRT serves as an expert resource for CDER on all botanical issues, and 
  • The BRT works with external regulatory and scientific groups, and presents at and participates in workshops to promote and enhance botanical drug product development and knowledge.

 



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